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CDER Seeks Firms for Site Tour Program

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Federal Register Notice: CDER plans to continue the Regulatory Project Management Site Tours and Regulatory Interaction Program an...

FDA Clears Blood Clot Risk Test

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FDA clears a Nanosphere, Inc. 510(k) for the Verigene F5 / F2 / MTHFR Nucleic Acid Test for detecting disease-associated gene muta...

Resource Lack Still Hampers FDA in China: Dingell, Barton

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Bipartisan congressional overseers find FDAs foreign drug inspections in China and India are still hampered by resource limitation...

Masoudi Rejoins FDA as Chief Counsel

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Former FDA deputy chief counsel Gerald F. Masoudi rejoins FDA as its new chief counsel.

Safety Alert Issued on Amylins Byetta

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FDA issues a safety alert on Amylin Pharmaceuticals Type 2 diabetes drug Byetta after reviewing 30 postmarketing reports of acute ...

FDA Covered Up Medtronic Problems: Public Citizen

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Sidney Wolfe asks why FDA didnt order a recall of Medtronic Sprint Fidelis defibrillators much earlier this year when reports of a...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Alternative Health Approaches, Dialysis Dimensions, EM Probe, and Washington Hos...

FDA Approves New BMS Breast Cancer Drug

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FDA approves BMS new chemotherapy drug Ixempra (ixabepilone) to treat advanced breast cancer in women whose tumors are resistant t...

Labopharm Seeks FDA Dispute Resolution on NDA

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Labopharm Inc. says it will seek formal dispute resolution with FDA over its concerns raised in a second approvable letter on its ...

Medtronic Pulls Faulty Defibrillator Leads

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Medtronic suspends sales and distribution of the Sprint Fidelis defibrillator leads due to the potential for lead fractures, which...